📊 Evidence-Based Reference

palmaz biliary stent

Johnson & Johnson Interventional Systems

Summary: The Palmaz Biliary Stent is a device used primarily for biliary duct obstructions. Key evidence highlights its use in managing acute recoil and AV fistula repair.

FDA Clearance Information

Pathway 510K
Decision Date February 5, 1991
Product Code DQY
Device Class Class 2
Evidence 0 studies

The Palmaz Biliary Stent was cleared by the FDA via the 510(k) pathway on February 5, 1991. It is manufactured by Johnson & Johnson Interventional Systems and classified as a Class 2 device.

What It Is

The Palmaz Biliary Stent is a metallic stent designed to maintain patency in biliary ducts. It is used in interventional procedures to prevent or treat obstructions.

Clinical Applications

Commonly used in the management of biliary obstructions, the Palmaz Biliary Stent is also applied in vascular interventions, such as addressing acute recoil and repairing arteriovenous fistulas.

Evidence Summary

The literature includes three studies from 1996 to 1998, focusing on various applications of the stent. These studies explore its use in coronary, vascular, and neurovascular interventions.

Reported Outcomes

Published studies report that the Palmaz Biliary Stent effectively manages acute recoil in coronary stenting and repairs popliteal arteriovenous fistulas. It also supports carotid angioplasty, potentially preventing strokes.

Safety Profile

Reported complications include acute elastic recoil in coronary applications, which can be managed with additional stenting. No other specific adverse events are detailed in the provided studies.

Evidence Limitations

The evidence is limited to a small number of studies with specific clinical scenarios. Further research is needed to generalize findings across broader patient populations and clinical settings.

Frequently Asked Questions

What are the clinical indications for Palmaz Biliary Stent?

The Palmaz Biliary Stent is indicated for maintaining patency in biliary ducts and has been used in vascular interventions such as managing acute recoil and repairing AV fistulas.

What outcomes have been reported in clinical studies?

Studies report successful management of acute recoil in coronary stenting and effective repair of popliteal AV fistulas. It also shows potential in preventing strokes through carotid angioplasty.

What complications have been reported?

Reported complications include acute elastic recoil in coronary applications, which may require additional stenting. No other specific complications are detailed in the studies provided.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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